Investigation of Polymorphisms in Bronchopulmonary Dysplasia In Turkish Population

NCT ID: NCT03467828

Last Updated: 2019-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 196 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-04
• Study Completion Date: 2018-05-24

Brief Summary

Bronchopulmonary dysplasia (BPD) is a chronic lung disease that affects a ratio of up to 20-30% of infants prematurely born before 30rd week. Delay of starting to speak, cerebral palsy and cognitive disorders may be seen in infants suffering from this disease. Although all the evidence found on the specific mediators and pathways that regulate the mechanism by studies made to understand the pathophysiologic mechanism, there hasn't been any remarkable progress on preventing the development of BPD in new-born infants born below 1500gr body weight. BPD is still one of the most important morbidity and mortality reasons in premature infants. There is a need of further studies to understand the genetic background of BPD specific to different populations, to identify polymorphisms related with the disease and for developing genetic methods for early the diagnose of the disease.

With this purpose, first of all polymorphisms related with BPD and those which are related with similar other lung diseases will be investigated. DNA samples derived from blood samples of 200 patients (100 BPD infant and 100 control) will be examined for polymorphisms in specific genes that are chosen in the light of the prior literature scanning. To the investigators' knowledge, this will be the first study of a broad scanning of polymorphisms related with BPD in Turkish population.

Detailed Description

Bronchopulmonary dysplasia is a chronic lung disease that affects a ratio of up to 20-30% of infants prematurely born before 30rd week. Delay of starting to speak, cerebral palsy and cognitive disorders may be seen in infants suffering from this disease. Although all the evidence found on the specific mediators and pathways that regulate the mechanism by studies made to understand the pathophysiologic mechanism, there hasn't been any remarkable progress on preventing the development of BPD in new-born infants born below 1500gr body weight. BPD is still one of the most important morbidity and mortality reasons in premature infants. There is a need of further studies to understand the genetic background of BPD specific to different populations, to identify polymorphisms related with the disease and for developing genetic methods for early the diagnose of the disease.

With this purpose, first of all polymorphisms related with BPD and those which are related with similar other lung diseases will be investigated. DNA samples derived from blood samples of 200 patients (100 BPD infant and 100 control) will be examined for polymorphisms in specific genes that are chosen in the light of the prior literature scanning. To the investigators' knowledge, this will be the first study of a broad scanning of polymorphisms related with BPD in Turkish population.

Conditions

Bronchopulmonary Displasia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Study Group

Infants diagnosed with BPD.

Group Type: EXPERIMENTAL

polymorphism analyzing

Intervention Type: GENETIC

Blood samples will be taken to EDTA containing tubes and then will be analyzed for genetic polymorphisms.

Control Group

Infants born in similar gestational week and birth weight but not diagnosed with BPD.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

polymorphism analyzing

Blood samples will be taken to EDTA containing tubes and then will be analyzed for genetic polymorphisms.

Intervention Type: GENETIC

Eligibility Criteria

Inclusion Criteria

• infants born under 30 gestational week
• infants with bronchopulmonary displasia

Exclusion Criteria

• major congenital abnormalities
• lack of data
• parents don't agree with informed consent

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Seda Yilmaz Semerci

OTHER

Sponsor Role: lead

Responsible Party

Seda Yilmaz Semerci

Neonatologist, MD

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Seda Yilmaz Semerci

Role: STUDY_CHAIR

Kanuni Sultan Suleyman Training and Research Hospital

Ayberk Akat

Role: PRINCIPAL_INVESTIGATOR

Istanbul Demiroglu Bilim University

Osman Mutluhan Ugurel

Role: STUDY_CHAIR

Yildiz Technical University

Merih Cetinkaya

Role: STUDY_DIRECTOR

Kanuni Sultan Suleyman Training and Research Hospital

Dilek Turgut Balık

Role: STUDY_DIRECTOR

Yildiz Technical University

Locations

Kanuni Sultan Suleyman Training and Research Hospital

Istanbul, Kucukcekmece, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Akat A, Yilmaz Semerci S, Ugurel OM, Erdemir A, Danhaive O, Cetinkaya M, Turgut-Balik D. Bronchopulmonary dysplasia and wnt pathway-associated single nucleotide polymorphisms. Pediatr Res. 2022 Sep;92(3):888-898. doi: 10.1038/s41390-021-01851-6. Epub 2021 Dec 1.

Reference Type: DERIVED

PMID: 34853430 (View on PubMed)

Other Identifiers

18

Identifier Type: -

Identifier Source: org_study_id